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临床试验/NCT04828083
NCT04828083已完成4 期

The Efficacy of Systemic Lidocaine Versus Ultrasound-guided Adductor Canal Block for Patients Undergoing Total Knee Arthroplasty: a Randomized, Double-blinded, Non-inferiority Study

Rhode Island Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2021年3月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
120
试验地点
1
主要终点
Postoperative opioid consumption

研究概览

简要总结

The investigators are evaluating the postoperative outcomes in patients undergoing total knee arthroplasty that receive either systemic lidocaine or ultrasound-guided adductor canal block as part of their anesthetic plan.

详细描述

Patients scheduled to have total knee arthroplasty will typically receive a single shot adductor canal block to serve as the primary anesthetic and as part of a multi-modal post-operative analgesic plan. The use of adductor canal block is still limited to where trained anesthesiologists in regional anesthesia are available. There are other nonopioid analgesic adjuncts, such as Lidocaine, which is is widely available and is a very commonly used local anesthetic. A major advantage of lidocaine is that it is not associated with a significant side effect profile. Intravenous lidocaine which can be administered during surgery and/or after surgery has demonstrated anti-inflammatory effects and can significantly decrease the reliance on opioid use for adequate pain management in abdominal and spine surgeries. The addition of systemic lidocaine infusion as part of a multimodal analgesia strategy to minimize opioid related side effects might prove to be a useful combination for clinicians where adductor canal blocks are not a viable option. However, the level of evidence comparing the efficacy of intravenous lidocaine versus adductor canal block to reduce postoperative opioid consumption in patients undergoing TKA is limited. We hypothesized that there will be no meaningful clinical difference between systemic lidocaine and ultrasound-guided adductor canal block in the 24-hour postoperative analgesia period.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ASA PS 1-3 patients undergoing primary, unilateral total knee arthroplasty

排除标准

  • ASA PS classification of 4 or greater
  • Pre-existing neuropathy
  • Coagulopathy
  • Chronic opioid consumption (>3 months)
  • Infection at the site
  • Known allergy to study medications (lidocaine)
  • High grade atrioventricular block (cardiac conduction system impairment)
  • A history of CVA/TIA
  • Currently using lidocaine patches
  • Known liver disease

研究组 & 干预措施

Ultrasound-guided adductor canal block with local anesthetic

Active Comparator

Single shot Ultrasound-guided adductor canal block with 0.5% ropivacaine 30 ml

干预措施: Saline IV (Drug)

Ultrasound-guided adductor canal block with saline

Sham Comparator

Single shot Ultrasound-guided adductor canal block with 30 mL of normal saline (Sodium chloride)

干预措施: Lidocaine IV (Drug)

结局指标

主要结局

Postoperative opioid consumption

时间窗: 24 hours

Postoperative opioid consumption will be converted to equivalent dose of oral morphine.

次要结局

  • Pain Scores(up to 2 hours (post anesthesia recovery unit), 6 hours, 12 hours, and 24 hours after surgery.)
  • Quality of Recovery(24 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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